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PF-06282999

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 31, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

PF-06282999 · 2 trials · 1 indication

Phase 1 2
NCT01707082A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy AdultsHealthy
COMPLETED69 Analytics
NCT01626976A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult SubjectsHealthy
COMPLETED42 Analytics
PHASE1COMPLETED
A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Apparent Oral Clearance (CL/F)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Minimum Observed Plasma Trough Concentration (Cmin)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Plasma Decay Half-Life (t1/2)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B

AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam

Average Concentration (Cav)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Accumulation Ratio
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to 24 hour [AUC24]
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
Apparent Volume of Distribution (Vz/F)
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
0 to 24 hours post-dose
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
0 to 24 hours post-dose
Renal Clearance (CLr)
0 to 24 hours post-dose
Oral temperature
0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose

Secondary Endpoints

Diastolic Blood Pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
interleukin-6
Days 1 and 14 pre-dose Part A
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A Cohort 1EXPERIMENTAL -
Part A Cohort 2EXPERIMENTAL -
Part A Cohort 3EXPERIMENTAL -
Part A Cohort 4EXPERIMENTAL -
Part A Cohort 5EXPERIMENTAL -
Part B Cohort 1EXPERIMENTAL -
Part B Cohort 2EXPERIMENTAL -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -

Interventions

NameTypeDescription
PF-06282999DRUGTablet, 10 mg, every 8 hours, 14 days
PlaceboDRUGTablet, 0 mg, every 8 hours, 14 days
midazolamDRUGTablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...

Countries:Belgium
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Frequently asked questions about PF-06282999

What is PF-06282999 used for?

PF-06282999 is an investigational small molecule being studied in healthy adult subjects. It is being evaluated for safety, tolerability, and pharmacokinetics, and for its effects on the approved drug midazolam. It is not approved for any disease and remains in clinical development.

Who makes PF-06282999?

PF-06282999 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting Phase 1 clinical trials to assess the drug's safety and effects in healthy volunteers.

What phase is PF-06282999 in?

PF-06282999 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy adult subjects.

What clinical trials is PF-06282999 in?

PF-06282999 has been studied in two completed Phase 1 trials: NCT01626976, which assessed safety, tolerability, and pharmacokinetics in 42 healthy adults, and NCT01707082, which tested safety and effects in 69 healthy overweight adults and effects on midazolam. Both trials were conducted in Belgium.

Is PF-06282999 the same as any other drug?

No alternative names for PF-06282999 have been disclosed. The drug is identified solely by its code name PF-06282999 in clinical trial records. It is a small molecule being developed by Pfizer.